LSC have a great contract opportunity for a Senior Regulatory Affairs Specialist to join a Galway based medical device company.
If you have minimum 3 years' experience in the medical device industry, with at least 2 years in a position in regulatory affairs or related/equivalent fieldand are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Provides regulatory advice to project teams.
- Guides conformance with applicable regulations in product development, support of claims and label content.
- Defines data and information needed for regulatory approvals. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Assist in the development of product reimbursement strategies. Lead applications for product reimbursements in line with company strategies.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function.
- Experience of inspection by an external agency, such as the FDA.
- Ability to work well under deadlines and pressure.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Pawel Jurkiewicz at +353 214771329 if you have any more questions about this opportunity!
